Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

NCT06569238 | Completed FDA Device

• 2 other identifiers: HUM00251960K23DK131261
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers. Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

Conditions

Diabetic Foot Ulcer; Diabetes Mellitus; Wound

Keywords

Wound Infection; Wound assessments; Wound's microbiome; Next generation sequencing

Outcome Measures

Primary Outcomes (1)

• The percent change in foot ulcer surface area square centimeter (cm2) after 12 weeks of observation for infected diabetic foot ulcers

  Baseline, 12 weeks

Secondary Outcomes (8)

• Percent of clinical resolved infected DFU for infected DFU participants with clinically resolved infection defined as improvement of greater or equal to two clinical signs of infection

  Baseline up to 12 weeks

• Total days of antibiotic therapy for the infected DFU participants

  Baseline up to 12 weeks

• Number of days to infection resolution for the infected DFU participants

  Baseline up to 12 weeks

• The percentage of participants with an infected DFU at baseline that resolve clinical infection by study week 4

  Baseline to 4 weeks

• The percentage of participants with an infected DFU at baseline that undergo a non-traumatic lower extremity amputation during the study.

  Baseline up to 12 weeks

Study Arms (2)

Conventional bacterial culture

ACTIVE COMPARATOR

Wound tissue removed will be sent for standard of care evaluation.

Diagnostic Test: Conventional bacterial culture

Conventional bacterial culture plus rapid diagnostic group

EXPERIMENTAL

Wound tissue removed will be sent for standard of care evaluation as well as rapid diagnostic with metagenomics next generation sequencing (mNGS).

Diagnostic Test: Conventional bacterial culture; Device: Rapid diagnostic group using mNGS technology

Interventions

Conventional bacterial culture DIAGNOSTIC_TEST

Participants will have DFU ulcer tissue collected and sent to the laboratory (per usual care practices) that includes the use of conventional bacterial culture analysis (i.e., plates).

Conventional bacterial culture; Conventional bacterial culture plus rapid diagnostic group

Rapid diagnostic group using mNGS technology DEVICE

Participants will have DFU ulcer tissue collected and have metagenomics sequencing performed. The name of the devices listed for this study are the Illumina MiSeq System with MiSeq Reagent Kit V2 from Illumina and the MinION sequencer (Oxford Nanopore Technologies).

Conventional bacterial culture plus rapid diagnostic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diabetes mellitus
• Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)
• o DFU Infection status will be clinically recorded at time of enrollment according to Infectious Disease Society of America (IDSA): mild, moderate, or severe infection
• Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months,
• Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

• Pregnant or lactating
• Uncontrolled blood glucose as demonstrated by a HbA1c of greater than 12%
• Bilateral wound or ulcer
• Current infection of Coronavirus disease 2019 (COVID19)
• Unable to provide informed consent or are unwilling to participate

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries; Wound Infection

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections

Study Officials

• Brian Schmidt, DPM

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: Participants will be randomized 1:1 to the control and intervention arms using block randomization. Only tissue review will be randomized.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: September 5, 2024
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)